Rekovelle

Medicinal product

(Invented) name

Rekovelle

Active substance (s)

Folitropinas delta

Strength

12 µg/0,36 ml

Pharmaceutical form

injekcinis tirpalas užpildytame švirkštiklyje

Route (s) of administration

leisti po oda

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

G03GA10, Follitropin delta

Marketing authorisation holder

Ferring Pharmaceuticals A/S, Danija

Date of authorisation

2016-12-22

Date of renewal

Documents

Search in EMA Europe

Stage

Registruotas

Controlled?

No

Controlled substance type

Legal basis

8(3)

Procedure number

Marketing authorisation procedure

Centrinė registracija

Qualitative and quantitative composition

Solution for injection in pre-filled pen	0.36 ml
Folitropinas delta	12 µg

Packages

PAKID	NPAKID	NPAKID-7	Pack type	Pack size	Type of packaging	Proposed dispensing/classification	Marketing authorisation no.	Supply status	From	To	Package is in foreign language	From	To	Mock-up
98507	84610	1084610	užpildytas švirkštiklis	N1 (+ 3 injekcinės adatos)		Receptinis	EU/1/16/1150/004	Tiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2016-12-22	Registruotas